201444Orig1s000

CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 201444Orig1s000 PROPRIETARY NAME REVIEW(S) Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Date: October 8, 2010 Application NDA# 201444 Type/Number: Through: Todd Bridges, RPh, Team Leader Denise Toyer, PharmD, Deputy Director Carol Holquist, RPh, Director Division of Medication Error Prevention and Analysis (DMEPA) From: Denise V. Baugh, PharmD, BCPS, Safety Evaluator Division of Medication Error Prevention and Analysis (DMEPA) Subject: Proprietary Name Review Drug Name(s): Nithiodote 1 vial of Sodium Nitrite Injection, USP, 300 mg/10 mL (30 mg/mL) 1 vial of Sodium Thiosulfate Injection, USP, 12.5 grams/50 mL (250 mg/mL) Applicant: Hope Pharmaceuticals, Inc. OSE RCM #: 2010-1360 *** Note: This review contains proprietary and confidential information that should not be released to the public.*** CONTENTS EXECUTIVE SUMMARY............................................................................................................. 2 1 BACKGROUND..................................................................................................................... 2 1.1 Introduction....................................................................................................................2 1.2 Regulatory History......................................................................................................... 2 1.3 Product Information ....................................................................................................... 2 2 METHODS AND MATERIALS ............................................................................................ 3 2.1 Search Criteria................................................................................................................ 3 2.2 FDA Prescription Analysis Studies................................................................................ 4 2.3 Adverse Event Reporting System (AERS) .................................................................... 4 3 RESULTS................................................................................................................................ 5 3.1 Database and Information Sources................................................................................. 5 3.2 CDER Expert Panel Discussion..................................................................................... 5 3.3 FDA Prescription Analysis Studies................................................................................ 5 3.4 AERS Cases................................................................................................................... 5 3.5 Safety Evaluator Risk Assessment................................................................................. 5 3.6 Comments from the Division of Anesthesia and Analgesia Products (DAAP)............. 6 4 DISCUSSION ......................................................................................................................... 6 4.1 Promotional Assessment................................................................................................ 6 4.2 Safety Assessment.......................................................................................................... 6 5 CONCLUSIONS AND RECOMMENDATIONS.................................................................. 6 5.1 Comments To The Applicant......................................................................................... 7 6 REFERENCES........................................................................................................................ 8 APPENDICES............................................................................................................................... 10 1 EXECUTIVE SUMMARY This review summarizes the Division of Medication Error Prevention and Analysis (DMEPA) proprietary name risk assessment for Nithiodote for co-packaged Sodium Nitrite Injection, USP (30 mg/mL) and Sodium Thiosulfate Injection, USP (250 mg/mL). Our evaluation did not identify concerns that would render the name unacceptable based on the product characteristics and safety profile known at the time of this review. Thus, DMEPA finds the proposed proprietary name, Nithiodote, acceptable for this product (See Section 4 for full discussion). DMEPA considers this a final review, however, if approval of the NDA is delayed beyond 90 days from the date of this review, the proposed proprietary name, Nithiodote, must be re-evaluated. Additionally, if any of the proposed product characteristics as stated in this review are altered, DMEPA rescinds this finding and the name must be resubmitted for review. The conclusions upon re-review are subject to change. 1 BACKGROUND 1.1 INTRODUCTION This review responds to a request from Hope Pharmaceuticals, Inc., submitted September 8, 2010, to evaluate the proposed proprietary name, Nithiodote, regarding promotional and potential name confusion with other proprietary or established drug names based on the product characteristics provided by the Applicant. The Applicant also submitted container labels and carton labeling which will be reviewed under separate cover (OSE Review #2010-1361). 1.2 REGULATORY HISTORY This NDA is a 505(b)(2) submission for a cyanide antidote containing one vial of sodium nitrite and one vial of sodium thiosulfate. The reference listed drug (RLD) for Nithiodote is sodium thiosulfate injection, USP (NDA # 020166), which was approved on February 14, 1992, (applicant was U.S. Army) to be given with sodium nitrite injection. However, the sodium thiosulfate injection drug product is no longer commercially available and there are no FDA- approved sodium nitrite and sodium thiosulfate products currently marketed in the United States. The only other available treatment for cyanide poisoning is Cyanokit (hydroxocobalamin) for injection (NDA# 022041) which was approved December 15, 2006. 1.3 PRODUCT INFORMATION Nithiodote, which is indicated for the treatment of (b) (4) cyanide poisonings, is composed of one vial of sodium thiosulfate injection and one vial of sodium nitrite injection co- packaged. The proposed dosing regimen is: 1) Inject intravenously 10 mL of a 3% solution (300 mg) of sodium nitrite at the rate of 2.5 to 5 mL/minute. The recommended dose of a 3% solution of sodium nitrite for children is 6 to 8 mL/m2 of body surface area (approximately 0.2 mL/kg of body weight) not to exceed (NTE) 10 ml of a 3% solution (300 mg). 2) Immediately thereafter, inject 50 mL of a 25% solution (12.5 g) of sodium thiosulfate for adults. The recommended dose of a 25% solution of sodium thiosulfate for children is 30 to 40 mL/m2 of body surface area (approximately 1 mL/kg of body weight) but 2 dosage should not exceed 50 mL of a 25% solution (12.5 g). The same needle and vein may be used. Personnel should acquire some skill in the proper method of administering sodium nitrite and sodium thiosulfate prior to an emergency. Cyanide poisoning is fatal. The patient should be watched closely for at least 24 to 48 hours. If signs of poisoning reappear, one-half of the original doses of both sodium nitrite and sodium thiosulfate should be repeated. Even if the patient seems perfectly well, the medication may be given for prophylactic purposes 2 hours after the first injections. If respiration has ceased but the pulse is palpable, artificial respiration should be applied at once. The purpose is not to revive per se, but to keep the heart beating. Each carton of Nithiodote consists of: • one 10 ml glass vial of Sodium Nitrite Injection 30 mg/mL (containing 300 mg of sodium nitrite); • one 50 mL glass vial of sodium thiosulfate injection 250 mg/mL (containing 12.5 grams of sodium thiosulfate); and • one package insert. The kit should be stored at controlled room temperature between 20 C and 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Protect from light. Do not permit to freeze. 2 METHODS AND MATERIALS Appendix A describes the general methods and materials used by the Division of Medication Error Prevention and Analysis (DMEPA) when conducting a proprietary name risk assessment for all proprietary names. Sections 2.1, 2.2 and 2.3 identify specific information associated with the methodology for the proposed proprietary name, Nithiodote. 2.1 SEARCH CRITERIA For this review, particular consideration was given to drug names beginning with the letter ‘E’ when searching to identify potentially similar drug names, as 75% of the confused drug names reported by the USP-ISMP Medication Error Reporting Program involve pairs beginning with the same letter.1,2 To identify drug names that may look similar to ‘Nithiodote’, the DMEPA staff also considers the orthographic appearance of the name on lined and unlined orders. Specific attributes taken into consideration include the length of the name (ten letters), upstrokes (5, one capital N, two lower case ‘t’, one lower case ‘h’, and one lower case ‘d’), down-strokes (none), dotted letters (2, lower case ‘i’) and cross-strokes (2, lower case ‘t’). Additionally, several letters in Nithiodote may be vulnerable to ambiguity when scripted (see Appendix B). As such, the DMEPA staff also considers these alternate appearances when identifying drug names that may look similar to Nithiodote. When searching to identify potential names that may sound similar to Nithiodote, the DMEPA staff searches for names with similar number

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